Nifedipine
- Product NDC
- 68084-598
- 11-digit product format
- 680840598
- Labeler code
- 68084
- Product ID
- 68084-598_35460830-1534-dc42-e063-6394a90a1e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077127
- Marketing category
- ANDA
- Marketing start
- 2013-09-09
- Substance
- NIFEDIPINE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nifedipine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIFEDIPINE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9ZF7L6G2L |
| Rxcui | 1812011, 1812013, 1812015 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-598-01 | Nifedipine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED, EXTENDED RE | 100 | | 10 |
| 68084-598-11 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 10 |
| 68084-598-65 | Nifedipine | 50 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 50 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NIFEDIPINE | ACTIVE INGREDIENT | I9ZF7L6G2L | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| NIFEDIPINE | ACTIVE MOIETY | I9ZF7L6G2L | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| CELLULOSE ACETATE | INACTIVE INGREDIENT | 3J2P07GVB6 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-598 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250522_b11026f8-dea0-49ac-8725-0ef7dc27923f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-598-01 | 68084059801 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-598-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-598-11) | 100 blister pack | 2013-09-09 | 0000-00-00 | No | No | Current |
| 68084-598-11 | 68084059811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-598-65 | 68084059865 | 50 BLISTER PACK in 1 CARTON (68084-598-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-598-11) | 50 blister pack | 2023-02-06 | | No | No | Current |